[Translation] A single-center, randomized, double-blind, placebo-controlled, single-dose escalation phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of SYH2059 tablets in healthy Chinese subjects
主要目的:评价SYH2059片单次口服给药在中国健康受试者中的安全性和耐受性。
次要目的:
1)评价SYH2059片单次给药在中国健康受试者中的药代动力学特征;
2)评价高脂餐对单次口服SYH2059片的药代动力学特征的影响;
3)中国健康受试者单次口服SYH2059片后的代谢产物鉴定及排泄途径研究;
4)评价健康受试者单次口服SYH2059片 后对QTcF间期的影响;
5)评价SYH2059片单次口服给药在中国健康受试者中的PD特征。
[Translation] Primary objective: To evaluate the safety and tolerability of a single oral dose of SYH2059 tablets in healthy Chinese subjects.
Secondary objectives:
1) To evaluate the pharmacokinetic characteristics of a single oral dose of SYH2059 tablets in healthy Chinese subjects;
2) To evaluate the effect of a high-fat meal on the pharmacokinetic characteristics of a single oral dose of SYH2059 tablets;
3) To identify metabolites and study their excretion pathways after a single oral dose of SYH2059 tablets in healthy Chinese subjects;
4) To evaluate the effect of a single oral dose of SYH2059 tablets on the QTcF interval in healthy subjects;
5) To evaluate the PD characteristics of a single oral dose of SYH2059 tablets in healthy Chinese subjects.